Merck KGaA, Oxygen Suspend Development of Drug Candidates

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Clinical development of two drug candidates was halted yesterday by Merck KGaA and Oxygen Biotherapeutics, with one citing additional unsuccessful results and the other, a lack of success in patient recruitment.

Merck KGaA cited a fresh set of disappointing results from a planned analysis of EMR 63325-009, a Phase I/II study in Japan, for its decision to scrap development of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).

The study was designed to assess tecemotide’s effects in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received chemoradiotherapy (CRT) concurrently or sequentially, with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy. Most patients in the study’s Phase II portion had received concurrent CRT.

The Phase I/II study missed its primary endpoint of overall survival (OS), and the secondary endpoints of progression-free survival (PFS), time to progression (TTP), and time to treatment failure. While the trial was not powered to demonstrate a statistically significant difference in benefit between the two arms, Merck KGaA said, it nevertheless stopped not only EMR 63325-009, but all other clinical trials with tecemotide in NSCLC worldwide sponsored by the company’s biopharmaceutical division.

Tecemotide, formerly named Stimuvax, is designed to stimulate the body’s immune system to identify and target cells expressing the cell-surface glycoprotein MUC1. The Phase I/II study was an effort to pinpoint a benefit for tecemotide in a subpopulation following the earlier failure of the Phase III START trial in 2013.

“While the data from the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals,” Luciano Rossetti, global head of research & development for Merck KGaA’s biopharmaceutical division, said in a company statement.

He said Merck KGaA will instead refocus its efforts on other promising pipeline candidates, citing by name the company’s anti-PD-L1 antibody MSB0010718C: “We remain committed to developing new treatment options for patients with difficult-to-treat cancers.”

Merck KGaA has sought to develop tecemotide since licensing it from Ono Pharmaceutical in 2001. Six years later, Merck KGaA obtained exclusive worldwide rights for developing and commercializing the drug candidate from Oncothyreon, in a deal that supplanted earlier agreements.

Oxygen, meanwhile said it will consider “strategic alternatives” to developing its Oxycyte drug candidate after a review of data from patients in a Phase IIb trial, following slower-than-planned patient enrollment. The Phase IIb study was designed to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).

“With the difficulties we have had enrolling patients at the current Phase IIb clinical sites for Oxycyte, the Oxygen Board of Directors and management team has decided that completing this trial in a reasonable period of time is not feasible,” Oxygen’s Chairman, Ronald Blanck, D.O., said in a statement.

A perfluorocarbon therapeutic oxygen carrier, Oxycyte has been in clinical and preclinical studies for intravenous delivery in indications such as TBI, decompression sickness, and stroke.

Oxygen added that it will refocus efforts going forward on its lead critical care product levosimendan, a calcium sensitizer in a Phase III trial in the U.S. for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In July, Oxygen launched the Phase III trial of levosimendan, which has been granted Fast Track status for its indication by the FDA. 








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